Quality by Design (QbD) for Biologics: A CDMO's Perspective

Sanofi breaks ground on an EU-backed insulin API plant in Frankfurt, Summit and ECOG-ACRIN launch a phase 2/3 trial of ivonescimab in first-line biliary tract cancer, and TaiMed’s anti-CD4 antibody TMB-365 lowers HIV viral load in phase 1.

Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains what is driving biopharma reshoring, how USMCA uncertainty complicates sourcing for biologics, and where cold-chain visibility still breaks down.

At PharmSci 360, Insilica CEO Thomas Luechtefeld will present on auditable agentic AI systems and how they are expanding computational toxicology beyond single predictive models.

Phase 1 data presented at IDWeek 2026 show TaiMed Biologics’ host-directed antibody TMB-365 lowered HIV-1 RNA without resistance, as the company advances an antibody-only maintenance regimen with TMB-380.

Dr Julie Gerberding and Dr David Berry will headline the October 25-28 New Orleans meeting, which adds a USP standards workshop and AI, organoid tracks.

Geneos Therapeutics has initiated a 90-patient randomized phase 2 trial comparing its personalized neoantigen DNA vaccine GNOS-PV02 with active surveillance in patients with high-risk hepatocellular carcinoma after surgery.

Backed by €400 million (US$449 million) in EU-cleared German aid, the new Frankfurt facility is designed to secure insulin supply for people with diabetes from 2032.

EA2251, the 7th registrational trial of ivonescimab, will test it plus chemotherapy vs pembrolizumab or durvalumab regimens in first-line BTC.